CSL has fleshed out the data from its phase 3 trial of garadacimab, a once-monthly therapy for hereditary angioedema (HAE), preparing regulatory filings and an attempt to
CSL and uniQure’s gene therapy for haemophilia B has been approved by the European Commission, ushering in a new era of therapy for patients with the bleeding disorder in
CSL's gene therapy for haemophilia B has been recommended for approval by the EMA's human medicine committee, setting up a decision by the European Commission early next year.
uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy fo
Bavarian Nordic is preparing to file for regulatory approval of a vaccine against chikungunya virus after its CHIKV VLP candidate showed protective efficacy in a second ph
To improve trial recruitment, engagement, and retention, and to increase the likelihood that trials reflect what matters most to patients, regulatory authorities increasingly point to metho